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厚労省 審査管理課が「治験関連文書における電磁的記録の活用に関する基本的考え方について」を発出(7/1)
厚生労働省医薬食品局審査管理課は、製薬企業および医療機関に向けた「治験関連文書における電磁的記録の活用に関する基本的考え方について」という事務連絡を発出いたしました。
本事務連絡は、治験依頼者等、治験審査委員会、実施医療機関の長及び治験責任医師との間で授受される治験関連文書を電磁的記録として保存等することに関する基本的考え方を示したものです。
これにより、治験手続きの効率化に寄与することを目的としています。
「治験関連文書における電磁的記録の活用に関する基本的考え方について」の考察
治験関連文書における電磁的記録の活用に関する基本的考え方について
厚生労働省医薬食品局審査管理課は、2013年7月1日に製薬企業および医療機関に向けた「治験関連文書における電磁的記録の活用に関する基本的考え方について」という事務連絡を発出した。
本事務連絡は、治験依頼者等、治験審査委員会、実施医療機関の長及び治験責任医師との間で授受される治験関連文書を電磁的記録として保存等することに関する基本的考え方を示したものである。
これにより、治験手続きの効率化に寄与することを目的としている。
これまではEDCシステムの導入により、医療機関から治験依頼者(製薬企業)に提出される症例報告書の電子化は進められてきた。
さらに電子化がすすめられる文書として、IRB関連文書、契約書、治験責任医師からの重篤な有害事象報告等が考えられる。
ただし、治験管理文書を電子化するためには、e文書法、厚生労働省令第44号、ER/ES指針等を遵守しなければならない。
治験関連文書における電磁的記録の活用に関する基本的考え方について問題点・課題
「治験関連文書における電磁的記録の活用に関する基本的考え方について」に関する問題点と課題以下のとおりである。
- GCP省令以外に、電子署名法、e-文書法、厚生労働省令第44号、ER/ES指針など、多くの電子化関連法令を遵守しなければならず、かつ難解である。
- 作成すべき手順書が多い。
- 電子文書をスキャンする際の要件(カラースキャナー、解像度、電子署名の付与)が具体的ではない。
- 厚生労働省令第44号では、治験関連文書を電磁的記録として保存する場合、見読性のみが求められているが、本事務連絡では、真正性、見読性、保存性の確保を要求している。
- 電子署名法に基づく電子署名は、特定認証局の認証を受けたデジタル署名であるが、本事務連絡では、デジタル署名を必須としていない。(電子署名法の遵守を義務付けていない)
「治験関連文書における電磁的記録の活用に関する基本的考え方について」逐条解説
治験関連文書における電磁的記録の活用に関する基本的考え方について
事務連絡
平成25年7月1日
各都道府県衛生主管部(局) 御中
厚生労働省医薬食品局審査管理課
治験関連文書における電磁的記録の活用に関する基本的考え方について
治験の実施に当たっては、「医薬品の臨床試験の実施の基準に関する省令」(平成9年厚生省令第28号。)において、治験に係る様々な文書の交付及び保存について定められていますが、電磁的記録の更なる活用により、これらの治験関連業務の効率化に資するものと期待されています。
今般、平成24年度厚生労働科学研究費補助金医薬品・医療機器等レギュラトリーサイエンス総合研究事業「医師主導治験等の運用に関する研究」においても、治験関連文書における電磁的記録の活用に関する基本的考え方についての検討がなされ、研究報告書がとりまとめられました。
つきましては、本研究報告書を踏まえ、治験関連文書における電磁的記録の活用に関する基本的考え方を別添のとおりとりまとめましたので、業務の参考として、貴管下関係業者及び医療機関等に対し周知いただきますよう御配慮願います。
1.趣旨
1.趣旨
治験の実施に当たっては、「医薬品の臨床試験の実施の基準に関する省令」(平成9年厚生省令第28号。以下「GCP省令」という。)に基づき、治験に係る様々な文書を交付及び保存(以下「保存等」という。)をする必要がある。
これらの業務は治験を実施する上で必要不可欠であるが、同時に治験審査委員会等の業務のIT化(審査資料の電子ファイル化等)及び実施医療機関における情報伝達の効率化等が求められている。
本文書は、治験依頼者等、治験審査委員会、実施医療機関の長及び治験責任医師との間で授受される治験関連文書を電磁的記録として保存等することに関する基本的考え方を示し、治験に関わる全ての関係者の認識を統一することにより、治験手続きの効率化に寄与することを目指すものである。
なお、本文書においては、GCP省令に基づき治験依頼者等と実施医療機関の長及び治験責任医師との間、実施医療機関の長と治験審査委員会との間で授受される治験関連文書(以下「治験関連文書」という。)を電磁的記録として保存等する場合を対象とした。
2.治験関連文書を電磁的記録として扱うことに関する法令上の整理
2.治験関連文書を電磁的記録として扱うことに関する法令上の整理
(1)e-文書法と厚生労働省令第44号
「民間事業者等が行う書面の保存等における情報通信の技術の利用に関する法律」(平成16年12月1日法律第149号。以下「e-文書法」という。)及び「厚生労働省の所管する法令の規定に基づく民間事業者等が行う書面の保存等における情報通信の技術の利用に関する省令」(平成17年3月25日厚生労働省令第44号。以下「省令第44号」という。)において、厚生労働省の所管する法令に係り、民間事業者等が書面により行わなければならないとされている文書の保存等を電磁的記録として行うことが認められている。
省令第44号では、電磁的記録として作成するための方法(第6条)、電磁的記録として交付するための方法(第11条第1項)、電磁的記録として保存するための方法(第4条第1項)及び電磁的記録として保存等できる文書の範囲(別表)が規定されている。
さらに別表第1の表2、表4又は表3に掲げる文書(医師法・歯科医師法に基づく診療録、薬剤師法に基づく処方せん等を含む。)を電磁的記録として保存する場合には、第4条第4項で規定される
①機器上への表示及び書面の作成ができること(見読性)、
②保存期間中の改変、消去について確認でき、責任の所在が明らかであること(真正性)、
③復元可能な状態で保存する措置を講じておくこと(保存性)
が求められており、別表第1の表1に掲げる文書(GCP省令に基づき交付される治験関連文書を含む。)を電磁的記録として保存する場合には、第4条第3項で規定される機器上への表示及び書面の作成ができること(見読性)が、別表第4に掲げる治験関連文書を電磁的記録として交付する場合には、第11条第2項で規定されるように当該記録が書面を作成することができるものであることが求められている。
(2)治験関連文書の電磁的記録としての交付及び保存
治験関連文書は、GCP省令において規定されている交付形態から、
①書面による交付が求められている治験関連文書、
②電磁的記録として交付することも可能とされる治験関連文書(GCP省令第10条又は第15条の7に基づき提出される事前提出資料等)、
③交付形態に関する規定はなく、利便性の問題から書面で交付される治験関連文書(GCP省令第20条又は第26条の6に基づき通知される副作用情報等)
に分類されているが、全て電磁的記録として交付することが可能である。
また、治験関連文書は省令第44号の別表第1の表1において、電磁的記録として保存できる文書としても規定されていることから、全て電磁的記録として保存することが可能である。
また、治験関連文書を電磁的記録として保存する場合、(1)で述べたように、 省令第44号第4条第3項で規定される見読性のみが求められており、同条第4項で規定される真正性、見読性、保存性まで求められていない。
しかしながら、治験関連文書を電磁的記録として保存する場合は、紙記録として保存する場合と同様に、治験に関する全ての情報を、正確に報告、解釈及び検証することが可能となるように記録し、取扱い及び保存する必要があることを踏まえると、真正性、見読性、保存性の確保が重要である。
なお、以下の(3)及び(4)に示す点にも留意する必要がある。
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